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使用决策辅助工具帮助考虑腹膜透析和中心血液透析的患者:一项随机对照试验。

Use of a Decision Aid for Patients Considering Peritoneal Dialysis and In-Center Hemodialysis: A Randomized Controlled Trial.

机构信息

Arbor Research Collaborative for Health, Ann Arbor, MI.

Arbor Research Collaborative for Health, Ann Arbor, MI.

出版信息

Am J Kidney Dis. 2019 Sep;74(3):351-360. doi: 10.1053/j.ajkd.2019.01.030. Epub 2019 Apr 4.

Abstract

RATIONALE & OBJECTIVE: Annually, about 100,000 US patients face the difficult choice between the most common dialysis types, in-center hemodialysis and peritoneal dialysis. This study evaluated the value of a new decision aid to assist in the choice of dialysis modality.

STUDY DESIGN

A parallel-group randomized controlled trial to test the efficacy of the decision aid on decision-making outcomes.

SETTING & PARTICIPANTS: English-speaking US adults with advanced chronic kidney disease and internet access enrolled in 2015.

INTERVENTION

Participants randomly assigned to the decision aid intervention received information about chronic kidney disease, peritoneal dialysis, and hemodialysis and a value clarification exercise through the study website using their own electronic devices. Participants in the control arm were only required to complete the control questionnaire. Questionnaire responses were used to assess differences across arms in decision-making outcomes.

OUTCOMES

Treatment preference, decisional conflict, decision self-efficacy, knowledge, and preparation for decision making.

RESULTS

Of 234 consented participants, 94 (40.2%) were lost to follow-up before starting the study. Among the 140 (70 in each arm) who started the study, 7 were subsequently lost to follow-up. Decision aid users had lower decisional conflict scores (42.5 vs 29.1; P<0.001) and higher average knowledge scores (90.3 vs 76.5; P<0.001). Both arms had high decisional self-efficacy scores independent of decision aid use. Uncertainty about choice of dialysis treatment declined from 46% to 16% after using the decision aid. Almost all (>90%) users of the decision aid reported that it helped in decision making.

LIMITATIONS

Limited generalizability from the study of self-selected study participants who had to have internet access, speak English, and have computer literacy. High postrandomization loss to follow-up. Evaluation of only short-term outcomes.

CONCLUSIONS

The decision aid improves decision-making outcomes immediately after use. Implementation of the decision aid in clinical practice may allow further assessment of its effects on patient engagement and empowerment in choosing a dialysis modality.

FUNDING

This study was funded through a Patient Centered Outcomes Research Institute (PCORI) award (#1109).

TRIAL REGISTRATION

Registered at ClinicalTrials.gov with study number NCT02488317.

摘要

背景与目的

每年,约有 10 万名美国患者面临在中心血液透析和腹膜透析这两种最常见的透析方式之间做出艰难选择。本研究旨在评估一种新的决策辅助工具在帮助选择透析方式方面的价值。

研究设计

一项平行组随机对照试验,旨在测试决策辅助工具对决策结果的疗效。

研究场所与参与者

2015 年,招募了有上网条件的英语为母语的美国成年人,这些成年人患有晚期慢性肾脏病。

干预措施

随机分配至决策辅助干预组的参与者通过研究网站使用自己的电子设备,获得关于慢性肾脏病、腹膜透析和血液透析的信息,并进行价值澄清练习。对照组的参与者仅需完成对照组问卷。通过问卷回答,评估两组在决策结果方面的差异。

结果

在 234 名同意参与的患者中,有 94 名(40.2%)在开始研究前失访。在开始研究的 140 名患者中(每组 70 名),有 7 名随后失访。决策辅助工具的使用者具有较低的决策冲突评分(42.5 分比 29.1 分;P<0.001)和较高的平均知识评分(90.3 分比 76.5 分;P<0.001)。无论是否使用决策辅助工具,两组的决策自我效能评分均较高。使用决策辅助工具后,对透析治疗选择的不确定性从 46%下降至 16%。几乎所有(>90%)使用决策辅助工具的患者都表示该工具有助于决策。

局限性

仅纳入了自我选择的研究参与者,这些参与者必须具备上网条件、讲英语且具备计算机使用能力,因此研究结果的普遍性有限。高失访率。仅评估短期结果。

结论

决策辅助工具可在使用后即刻改善决策结果。在临床实践中实施决策辅助工具可能有助于进一步评估其对患者参与选择透析方式和增强其能力的影响。

资金来源

本研究由患者导向的医疗成果研究所(PCORI)资助(#1109)。

临床试验注册

ClinicalTrials.gov 注册号:NCT02488317。

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